A biopsy is the removal of tissue to examine it for signs of cancer or other disorders. Biopsies may be open (surgically removing tissue) or percutaneous (e.g. by fine needle aspiration, core needle biopsy or vacuum assisted biopsy). The biopsy site can be located via palpation, ultrasound, stereotactic, MRI or mammography.
Biopsy samples are obtained in a variety of ways using various medical procedures involving a variety of the sample collection devices. Examples of collection devices include those marketed under the tradenames MAMMOTOME (from DEVICOR MEDICAL PRODUCTS, Cincinnati Ohio), CELERO, ATEC AND EVIVA (all from HOLOGIC, Malborough Mass.), and FINESSE and ENCOR (all from BARD BIOPSY SYSTEMS, Tempe Ariz.).
Some of these systems collect the biopsy sample in a closed container. U.S. Pat. No. 8,118,775 describes a closed biopsy sample storage container that is designed to spatially segregate biopsy samples during the collection procedure. U.S. Pat. No. 7,572,236 describes a biopsy device with a closed container for collecting one or more samples. The container includes a basket for flushing away blood and other tissue debris from the specimens.
After the biopsy sample is collected, the sample is analyzed at a lab that is set up to perform the appropriate tests (such as histological analysis). Often, collection of the sample, and analysis of the sample are performed at different locations and the sample must be transported from the collection location (e.g. hospital, clinic, etc.) to the pathology lab for analysis.
Thus, after collection, the biopsy samples are typically removed from the collection container and placed into another container for transport to a pathology lab. A chemical fixative (such as formalin) is added to the container to preserve the sample.
After the samples are removed from the patient, a tissue marker can be inserted into the biopsy site to later relocate the site, if needed. For example, U.S. Pat. Nos. 6,270,464, 6,356,782, 6,699,205, 7,229,417 and 7,625,397 all describes tissue markers and methods for marking a biopsy site.
It is desirable to retain information collected during the biopsy with each sample. It is also desirable to be able to later relocate the position that the sample was taken from the biopsy site by correlating information retained with the sample against the tissue marker.
Thus, there is a need for the sample or samples to be packaged for transportation from the collection location to the pathology lab. Currently, the sample is simply placed loosely in a specimen jar filled with the fixing agent or chemical (e.g., a solution of formaldehyde in water such as Formalin), which preserves the biopsy sample for analysis and the specimen jar sealed for shipping. If multiple samples are collected, multiple samples from the same patient may be placed in the same jar for transportation.
Once the biopsy sample arrives in the pathology lab, it is removed from the container placed, into a cassette and processed it is then embedded ready for sectioning. It is often necessary to slice the sample into a plurality of thin sections (e.g., 2 to 25μ thick sections), often using a microtome, prior to performing any analysis. Such sectioning of the sample often helps a medical professional properly assess the sample under a microscope (e.g. diagnose relationships between cells and other constituents of the sample, or perform other assessments). In order to properly section the sample, several steps are typically performed to embed the sample within a solid substrate. A commonly used solid substrate may include, for example, paraffin wax, which is used to hold the sample in position while also providing a uniform consistency to further facilitate sectioning with the microtome. In order to properly process the sample a series of steps must be performed including:                1—Fixation of the sample to immobilize molecular components and/or prevent degradation. This is typically done with a fixing agent or chemical (e.g., a solution of formaldehyde in water such as formalin) shortly after sample collection.        2—Transferring the sample from the transportation jar to a processing cassette.        3—Infiltrating the sample with an embedding material, such as the paraffin wax.        4—Embedding the sample in the paraffin wax and sectioning using for example a microtome.        
Under existing practices, this fixing, transferring, infiltrating, and embedding must all be done manually, and such manual handling of the sample can increase the likelihood of misidentifying the sample, cross contaminating the samples, or losing part or all of the sample. Further, as multiple samples may be placed in the same jar, and each sample is merely loosely floating in the fixing agent, information about each sample, such as the orientation of the sample with respect to collection and, which sample was collected from which area of the patient (i.e., 2 mm from mass, 4 mm from mass, 6 mm from mass etc.) may be lost and unavailable to the medical professional when assessing the sample. Additionally, the numerous steps of manual manipulation can often increase the time that it takes to provide a proper assessment for each sample, once the sample is collected from the patient.